AccessGUDID - DEVICE: JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW (06934955937385)

GUDID

Device Identifier (DI) Information

Brand Name: JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
Version or Model: 5955-015-12
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5955-015-12
Company Name: OrbusNeich Medical (ShenZhen) Co., Ltd.

Primary DI Number: 06934955937385
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530923226 *Terms of Use

Device Description: Percutaneous Transluminal Angioplasty Balloon Catheter

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17184	Peripheral angioplasty balloon catheter, basic	A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIT	Catheter, Angioplasty, Peripheral, Transluminal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241025	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fddcde6c-45ef-4890-a51d-31901cd274fc
Public Version Date: July 29, 2024
Public Version Number: 1
DI Record Publish Date: July 20, 2024